Amgen Specialist IS Business Systems Analyst - Thousand Oaks IS Operations in Thousand Oaks, California
Amgen is seeking a Specialist IS (Information Systems) Business Systems Analyst - Thousand Oaks IS Operations on our IS Operations team, to be based in our global headquarters in Thousand Oaks, CA. This position will report to the Director of IS Operations and will primarily be responsible for supporting various functions and applications within the ATO (Thousand Oaks, CA) Site Operations organization.
The Specialist will work with stakeholders in Operations (Process Development, Manufacturing, Supply Chain, and Quality) as well as other stakeholders in Operations IS and Enterprise IS, to define and implement strategic initiatives and applications while adhering to Amgen standards, policies and procedures.
Responsibilities of the Specialist include:
System ownership and support of critical applications
Maintain and update inspection readiness for critical applications, including inspection readiness playbook, periodic assessments (data integrity, security, system compliance)
Develop test script protocols in support of projects
Develop validation protocols such as Requirements and Design Specifications, Installation and Operational Qualification documents
Maintain and build relationships with key business stakeholders
Escalate as appropriate problems and issues to management
Participate in proactive state of the art research and provide recommendations for continuous improvement
Master's degree and 3 years of Information Systems experience
Bachelor's degree and 5 years of Information Systems experience
Associate's degree and 10 years of Information Systems experience
High school diploma / GED and 12 years of Information Systems experience
5+ years' experience supporting enterprise scale applications
Strong demonstrated knowledge of validation and cGMP (including change control processes, 21 CFR Part 11, validation, and should be able to write validation protocols such as Validation Plans, Requirements Specifications, Design Specifications, IQs, OQs, and be able to execute the validation protocols)
General and/or good understanding of process and product manufacturing related applications such as Data Historians, Manufacturing Execution Systems, Supervisory Control and Data Acquisition (SCADA) systems, and Laboratory Information Management Systems (LIMS) as well as experience with evaluating and deploying emerging technologies such as artificial intelligence, machine learning, and advanced analytics
History of analytical and troubleshooting skills
Experience with System Development Life Cycle processes
Biotechnology, pharmaceutical, or healthcare experience
Excellent verbal and written communication skills
Self-starter with a high degree of initiative
Highly motivated and able to work effectively under minimal supervision
Team-oriented, placing priority on the success of the organization
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.